HEINE BETA 200(R) OPHTHALMOSCOPE
FDA 510(k) clearance K131961 · decided 2013-12-04
Clearance details
- K-number
- K131961
- Device name
- HEINE BETA 200(R) OPHTHALMOSCOPE
- Applicant
- Heine Optotechnik GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2013-06-27
- Decision date
- 2013-12-04
- Days to decision
- 160 days
- Clearance type
- Abbreviated
- Product code
- HLJ
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Herrsching, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Heine Optotechnik GmbH & Co. KG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.